BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SERODIA TP-PA

    K Number: K971502 · Decision Nov 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    SERODIA TP-PA
    K Number
    K971502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scimedx Tekfile Services
    Date Received
    April 24, 1997
    Decision Date
    November 13, 1997
    Product Code
    GMT
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GMT Antigens, Ha, Treponema Pallidum

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